MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-07 for CONSULT HCG URINE CASSETTE 5001 25T FHC-A102 manufactured by Alere San Diego, Inc..
[188846607]
At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere (b)(4). Alere (b)(4) updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions. This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere (b)(4) (reference eir (b)(4)). The awareness date is based on updated reporting decisions and completion of the retrospective review activity. There is no new or increased trend based on this retrospective review activity. Investigation conclusion: the customer's results were not replicated in-house with retention products of the reported lot. Retention products were tested with clinical negative urine and an hcg urine standard below the qc cutoff. All devices produced negative hcg results at the read time and met the qc specification. No false positive results were observed. Manufacturing batch record review did not uncover any abnormalities. A root cause could not be determined from the information provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[188846608]
(b)(6) 2017: patient presented to facility for a routine pre-op procedure. A urine specimen was tested on the consult diagnostics hcg urine cassette and positive result was obtained. Confirmatory quant provided a negative result of <2 miu/ml. The operation was not postponed due to the false positive result. No adverse outcomes reported. Troubleshooting was performed focusing on possible causes such as deviations in storage, technique, handling and patient specimen factors as specified in the corresponding package insert, no deviations were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2019-00352 |
| MDR Report Key | 9560194 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2017-04-24 |
| Date Mfgr Received | 2019-07-19 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MONIKA BURRELL |
| Manufacturer Street | 9975 SUMMERS RIDGE RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052506 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONSULT HCG URINE CASSETTE 5001 25T |
| Generic Name | PREGNANCY TEST |
| Product Code | JHI |
| Date Received | 2020-01-07 |
| Model Number | FHC-A102 |
| Lot Number | HCG6080010 |
| Device Expiration Date | 2018-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |